NCT04185532

Brief Summary

This study evaluates the use of a brace in acute anterior cruciate ligament (ACL) injuries in children and adolescents. Half of the participants will receive a so called rebound ACL brace together with a standardized rehab program supervised by a physiotherapist, while the other half will receive only the standardized rehab program supervised by a physiotherapist

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 8, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

4.9 years

First QC Date

November 25, 2019

Last Update Submit

December 17, 2024

Conditions

Anterior Cruciate Ligament InjuriesAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament Tear

Keywords

ACLchildren and adolescentsrebound ACL brace

Outcome Measures

Primary Outcomes (9)

  • Objective knee function

    laxity measurement (KT-1000)

    6 months

  • Objective knee function

    laxity measurement (KT-1000)

    12 months

  • Objective knee function

    laxity measurement (KT-1000)

    24 months

  • objective knee function

    muscle strength (measured by Biodex)

    6 months

  • objective knee function

    muscle strength (measured by Biodex)

    12 months

  • objective knee function

    muscle strength (measured by Biodex)

    24 months

  • objective knee function

    jump tests

    6 months

  • objective knee function

    jump tests

    12 months

  • objective knee function

    jump tests

    24 months

Secondary Outcomes (3)

  • Subjective knee function

    6, 12 and 24 months

  • Subjective knee function

    6, 12 and 24 months

  • Activity level

    6, 12 and 24 months

Study Arms (2)

Rebound ACL brace and physiotherapy

EXPERIMENTAL

The intervention will be the use of rebound ACL brace for 9 weeks, which initially is locked followed by a gradually increased range of motion. A standardized rehab protocol is applied.

Other: Rebound ACL brace and physioterapy

Physiotherapy

ACTIVE COMPARATOR

A standardized rehab protocol comparable to the experimental group but with no brace

Other: Physioterapy

Interventions

Rebound ACL brace and physioterapyOTHER

Usage of rebound ACL brace and physioterapy supervised by physioterapist

Rebound ACL brace and physiotherapy
PhysioterapyOTHER

Physioterapy supervised by physioterapist

Physiotherapy

Eligibility Criteria

AgeUp to 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No previous significant knee injury
  • Trauma followed by hemarthrosis and clinical suspicion of an acute ACL injury
  • Acute ACL rupture seen on MRI

You may not qualify if:

  • Previous ipsilateral knee surgery
  • Associated injuries which require early surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capio Artro Clinic

Stockholm, Sverige, 113 41, Sweden

Location

Related Publications (1)

  • Jacobi M, Reischl N, Ronn K, Magnusson RA, Gautier E, Jakob RP. Healing of the Acutely Injured Anterior Cruciate Ligament: Functional Treatment with the ACL-Jack, a Dynamic Posterior Drawer Brace. Adv Orthop. 2016;2016:1609067. doi: 10.1155/2016/1609067. Epub 2016 Dec 7.

    PMID: 28053787BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Frida Hansson, MD, PhD stud

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The knee laxity measurement with KT-1000 will be performed by an assessor without knowledge of type of intervention. Other outcome measures will not be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD. Principal Investigator. PhD student

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 4, 2019

Study Start

January 8, 2020

Primary Completion

December 17, 2024

Study Completion

December 17, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning 3 months and ending minimum 5 years following article publication
Access Criteria
Proposals should be directed to frida.hansson@capio.se. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
More information

Locations

SE(1)